Sensory Morbidity Following Breast Surgery

NCT00625924 | Completed

• 1 other identifier: 08-009
• Study Type: observational
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of the study is measure breast sensations after breast surgery. The results of this study will help surgeons better understand breast sensations and may improve the way surgery is done.

Conditions

Breast Cancer

Keywords

Plastic surgery; reconstruction

Outcome Measures

Primary Outcomes (1)

• To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.

  conclusion of the study

Secondary Outcomes (1)

• To compare sensory morbidity following three types of breast surgery: tissue expander/implant breast reconstruction, autogenous tissue reconstruction, and no reconstruction.

  conclusion of the study

Study Arms (3)

1

autogenous tissue breast reconstruction

Behavioral: questionnaires

2

tissue expander/implant breast reconstruction

Behavioral: questionnaires

3

mastectomy alone

Behavioral: questionnaires

Interventions

questionnaires BEHAVIORAL

Patients will be evaluated at one time point using the Breast Sensation Assessment Score (BSAS©), the SF-36 Health Survey, the MSKCC BREAST Q, the Brief Pain Inventory, the Hopwood Body Image Scale, the Profile of Mood States - Brief Version (POMS - BRF), and the 'Patient Demographic and Treatment Information Form'

1

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

You may qualify if:

• The Samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-5 years of enrollment.
• Patients who have undergone immediate, two-stage expander/implant postmastectomy reconstruction
• Patients who have undergone immediate, autogenous tissue flap reconstruction following mastectomy
• Patients who have undergone mastectomy alone
• Patients at least 21 years of age
• Patients who completed mastectomy ± immediate post-mastectomy reconstruction at least one year but no longer than five years prior to study entry

You may not qualify if:

• Patients who have had any of the following:
• delayed reconstruction (no reconstruction at time of surgery) combined autogenous tissue/implant breast reconstruction, and/or
• Patients who have a pre-surgical history of complex regional pain syndrome
• Patients who have had radiation therapy
• Patients who have had a local recurrence
• Patients who do not speak the English language (validated translations of key questionnaires are not available).

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andrea Pusic, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: January 16, 2014

Record last verified: 2014-01

Locations

US (1)